Expandable support device and method of use

ABSTRACT

An expandable support device for tissue repair is disclosed. The device can be used to repair hard or soft tissue, such as bone or vertebral discs. A method of repairing tissue is also disclosed. The device and method can be used to treat compression fractures. The compression fractures can be in the spine. The device can be deployed by compressing the device longitudinally resulting in radial expansion.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/689,465, filed Mar. 21, 2007, which is a continuation-in-part of PCTApplication No. PCT/US2005/037126, filed Oct. 12, 2005 which claimspriority to U.S. Provisional Application No. 60/617,810, filed Oct. 12,2004; a continuation-in-part of PCT Application No. PCT/US2005/034115,filed Sep. 21, 2005, which claims priority to U.S. ProvisionalApplication No. 60/612,001, filed Sep. 21, 2004; and acontinuation-in-part of PCT Application No. PCT/US2005/034742, filedSep. 26, 2005, which claims priority to U.S. Provisional Application No.60/612,723, filed Sep. 24, 2004, and U.S. Provisional Application No.60/612,724, filed Sep. 24, 2004, all of which are incorporated byreference herein in their entirety. This application also claims thebenefit of all of the above-referenced U.S. Provisional applications.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to devices for providing support for biologicaltissue, for example to fuse vertebral bodies, repair herniated discs,and/or repair spinal compression fractures, and methods of using thesame.

2. Description of Related Art

Some conditions of the spine result from degradation or injury to thebone structures of the spine, typically the vertebral body. These can bethe result of bone degeneration such as through osteoporosis or trauma,such as compression fractures. breakdown or injury to the boneystructures in the spine can result in pain and spinal deformity withcomorbidities.

Vertebroplasty is an image-guided, minimally invasive, nonsurgicaltherapy used to strengthen a broken vertebra that has been weakened bydisease, such as osteoporosis or cancer. Vertebroplasty is often used totreat compression fractures, such as those caused by osteoporosis,cancer, or stress.

Vertebroplasty is often performed on patients too elderly or frail totolerate open spinal surgery, or with bones too weak for surgical spinalrepair. Patients with vertebral damage due to a malignant tumor maysometimes benefit from vertebroplasty. The procedure can also be used inyounger patients whose osteoporosis is caused by long-term steroidtreatment or a metabolic disorder.

Vertebroplasty can increase the patient's functional abilities, allow areturn to the previous level of activity, and prevent further vertebralcollapse. Vertebroplasty attempts to also alleviate the pain caused by acompression fracture.

Vertebroplasty is often accomplished by injecting an orthopedic cementmixture through a needle into the fractured bone. The cement mixture canleak from the bone, potentially entering a dangerous location such asthe spinal canal. The cement mixture, which is naturally viscous, isdifficult to inject through small diameter needles, and thus manypractitioners choose to “thin out” the cement mixture to improve cementinjection, which ultimately exacerbates the leakage problems. The flowof the cement liquid also naturally follows the path of least resistanceonce it enters the bone—naturally along the cracks formed during thecompression fracture. This further exacerbates the leakage.

The mixture also fills or substantially fills the cavity of thecompression fracture and is limited to certain chemical composition,thereby limiting the amount of otherwise beneficial compounds that canbe added to the fracture zone to improve healing. In an alternativeprocedure known as kyphoplasty, a balloon is first inserted in thecompression fracture and the vertebra and is expanded to create a voidbefore the cement is injected into the newly formed space.

A vertebroplasty device and method that eliminates or reduces the risksand complexity of the existing art is desired. A vertebroplasty deviceand method that may reduce or eliminate the need to inject a liquiddirectly into the compression fracture zone is also desired.

Other ailments of the spine result in degeneration of the spinal disc inthe intervertebral space between the vertebral bodies. These includedegenerative disc disease and traumatic injuries. In either case, discdegeneration can cause pain and other complications. Conservativetreatment can include non-operative treatment requiring patients toadjust their lifestyles and submit to pain relievers and a level ofunderlying pain. Operative treatment options include disc removal. Thiscan relieve pain in the short term, but also often increases the risk oflong-term problems and can result in motor and sensory deficienciesresulting from the surgery. Disc removal and more generally discdegeneration disease are likely to lead to a need for surgical treatmentin subsequent years. The fusion or fixation will minimize orsubstantially eliminate relative motion between the fixed or fusedvertebrae. In surgical treatments, adjacent vertebra can be fixated orfused to each other using devices or bone grafts. These may include, forexample, screw and rod systems, interbody spacers (e.g., PEEK spacers orallograft bone grafts) threaded fusion cages and the like.

Some fixation or fusion devices are attached to the vertebra from theposterior side. The device will protrude and result in additional length(i.e., needed to overlap the vertebrae) and additional hardware toseparately attach to each vertebrae. Fusion cages and allografts arecontained within the intervertebral space, but must be inserted into theintervertebral space in the same dimensions as desired to occupy theintervertebral space. This requires that an opening sufficient to allowthe cage or graft must be created through surrounding tissue to permitthe cage or graft to be inserted into the intervertebral space.

A spinal fixation or fusion device that can be implanted with or withoutthe need for additional hardware is desired. Also desired is a fixationor fusion device that can be deployed in a configuration whereoverlapping the fixated or fused vertebrae is not required.

Also desired is an intervertebral device the may be inserted in to theintervertebral space at a first smaller dimension and deployed to asecond, larger dimension to occupy the intervertebral space. The abilityto insert an intervertebral spacer at a dimension smaller than thedeployed dimension would permit less disruption of soft and boney tissuein order to access the intervertebral space.

An effective therapy for following up a discectomy is desired. Avertebral fusion technique that can be used subsequent to a discectomyis desired.

SUMMARY OF THE INVENTION

An expandable support device that can be used to repair fractures andstabilize hard tissue, such as via intravertebral or intervertebraldeployment, is disclosed. The expandable support device can have alongitudinal axis and a radial axis. The expandable support device canbe configured, for example by design of the cells, voids or holes in thewall, to expand radially when compressed longitudinally. The expandablesupport device can be made from an integral piece of metal.

An expandable support device for performing completely implantablespinal repair is disclosed. The device has a first strut and a secondstrut attached to, and/or integral with, the first strut. The firststrut is substantially deformable. The second strut can be substantiallyinflexible.

The device can be configured to expand in a single direction. The devicecan be configured to expand in two directions.

The device can have a buttress. The buttress can have, for example, acoil, a wedge, and/or a hoop.

The device can have a locking pin. The locking pin can be interferencefit with the device, for example with the first strut, and/or with alongitudinal port of the device.

Methods for deploying an expandable support device in the spine aredisclosed. The expandable support device can be deployed, for example,by longitudinal compression. The longitudinal compression can result inradial expansion of the expandable support device. The expandablesupport device can be deployed in an intravertebral site. The expandablesupport device can be deployed in an intervertebral site.

Methods for repairing a damaged section of a spine are also disclosed.The methods include expanding an expandable support device in thedamaged section. The expandable support device is loaded on a balloonduring the expanding. Expanding includes inflating a balloon. Inflatingthe balloon includes inflating the balloon equal to or greater thanabout 5,000 kPa of internal pressure, or equal to or greater than about10,000 kPa of internal pressure.

Tools for deploying an expandable support device are disclosed. Thetools can be configured to apply a compressive force on the expandablesupport device along the expandable support device's longitudinal axis.The tools can be configured to securely engage the expandable supportdevice. The tools can be configured to removably attach to opposingpoints at or near opposing longitudinal ends of the expandable supportdevice. Actuation of the tool to apply a compressive force may includesqueezing two handles together or rotating a knob or handle.

In all configurations and contemplated uses, the expandable device maybe filled with a material suitable for the contemplated use. By way ofexample, when used to treat compression fractures, it is contemplatedthat a suitable material such bone cement, tissue or bone growthfactors, bone morphogenic proteins, stem cells, carriers for any of theforegoing, or mixtures thereof may be inserted within the expandabledevice to provide support, fixation and/or improved bone structure. Inthe case of growth factors or stem cells, it is contemplated these maybe obtained autologously, such as from the patient's own blood or bonemarrow aspirate. By way of further example, when the device is used asan intervertebral spacer for fusion, it is contemplated that theexpandable device may be filled with autograft, allograft, boneextenders (e.g., calcium phosphate or tricalcium phosphate or mixturesthereof or other similar materials), bone growth factors, bonemorphogenic proteins, stem cells, carriers for any of the foregoing, andmixtures thereof. As contemplated above, growth factors and stem cellsmay be commercially available or may be extracted from the patient's ownblood or bone marrow aspirate.

In addition, it is contemplated that the ratio of the expansion for theexpandable devices (the ratio of the unexpanded height or diameter,depending on configuration, to the expanded height or diameter) may befrom 1:2 to 1:5 or greater. For intravertebral and intervertebralapplications applicants have found that expansion ratios of from about1:3 to about 1:4 are acceptable. For vertebroplasty or interbodyapplications it is contemplated that a device having an initial heightor diameter from about 4 mm (0.16 in.) to about 8 mm (0.31 in.) and anexpanded height or diameter from about 7 mm (0.28 in.) to about 18 mm(0.71 in.) may be desirable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 through 3 are side perspective views of various variations ofthe expandable support device.

FIGS. 4 through 6 illustrate various variations of cross-section A-A ofthe expandable support device.

FIG. 7 through 10 are side perspective views of various variations ofthe expandable support device.

FIG. 11 is a side perspective view of a variation of the expandablesupport device in a contracted configuration.

FIGS. 12 through 14 illustrate a variation of a method of deployingmultiple expandable support devices.

FIG. 15 is a schematic figure of a variation of the expandable supportdevice in a contracted configuration.

FIG. 16 is a schematic figure of a variation of the expandable supportdevice of FIG. 15 in an expanded configuration.

FIG. 17 is a perspective view of a variation of the expandable supportdevice.

FIG. 18 is a side view of the variation of the expandable support deviceof FIG. 17.

FIG. 19 is a top view of the variation of the expandable support deviceof FIG. 17.

FIG. 20 is a front view of the variation of the expandable supportdevice of FIG. 17.

FIG. 21 is a perspective view of a variation of the expandable supportdevice.

FIG. 22 is a side view of the variation of the expandable support deviceof FIG. 21.

FIG. 23 is a front view of the variation of the expandable supportdevice of FIG. 21.

FIG. 24 is a perspective view of a variation of the expandable supportdevice.

FIG. 25 is a front view of the variation of the expandable supportdevice of FIG. 24.

FIG. 26 illustrates a flattened pattern for a variation of theexpandable support device.

FIG. 27 is a perspective view of a variation of the expandable supportdevice.

FIG. 28 is a front view of the variation of the expandable supportdevice of FIG. 27.

FIG. 29 is a perspective view of a variation of the expandable supportdevice.

FIG. 30 is a front view of the variation of the expandable supportdevice of FIG. 29.

FIG. 31 is a perspective view of a variation of the expandable supportdevice.

FIG. 32 is top view of the variation of the expandable support device ofFIG. 31.

FIG. 33 is a side view of the variation of the expandable support deviceof FIG. 31.

FIG. 34 is a front view of the variation of the expandable supportdevice of FIG. 31.

FIG. 35 illustrates a variation of section A-A of the variation of theexpandable support device of FIG. 31.

FIG. 36 illustrates a variation of section B-B of the variation of theexpandable support device of FIG. 31.

FIG. 37 is a side perspective view of a variation of the expandablesupport device.

FIG. 38 is a front view of the variation of the expandable supportdevice of FIG. 37.

FIG. 39 is a rear perspective view of the variation of the expandablesupport device of FIG. 37.

FIG. 40 is a bottom view of the variation of the expandable supportdevice of FIG. 37.

FIG. 41 is a side view of the variation of the expandable support deviceof FIG. 37.

FIGS. 42 and 43 are side views of various variations of the expandablesupport device.

FIG. 44 is a side perspective view of a variation of the expandablesupport device.

FIGS. 45 through 47 are front views of various variations of theexpandable support devices.

FIG. 48 is a top perspective view of a variation of the expandablesupport device.

FIG. 49 is top view of the variation of the expandable support device ofFIG. 48.

FIG. 50 is a front view of the variation of the expandable supportdevice of FIG. 48.

FIGS. 51 and 52 illustrate a variation of a method for using a deliverysystem for the expandable support element.

FIGS. 53 through 55 illustrate a variation of a method for accessing adamage site in the vertebra.

FIG. 56 illustrates two methods for delivering expandable supportdevices to the vertebral column.

FIGS. 57 through 62 illustrate various methods for deploying theexpandable support device into the damage site in the vertebra.

FIGS. 63 and 64 illustrate a variation of a method for deploying one ormore expandable support devices into one or more damage sites in thevertebra.

FIG. 65 illustrates a variation of a method for deploying the expandablesupport device into the damage site in the vertebra.

FIG. 66 illustrates a variation of a method for deploying the expandablesupport device into the damage site in the vertebra.

FIG. 67 illustrates variations of methods for deploying the expandablesupport device into the damage site in the vertebra.

FIGS. 68 and 69 illustrate a variation of a method for deploying theexpandable support device into the damage site in the vertebra.

FIGS. 70 and 71 illustrate a variation of a method for deploying alocking pin into the expandable support device in the damage site in thevertebra.

FIGS. 72 through 77 illustrate a variation of a method for deploying alocking pin into the expandable support device.

FIG. 78 illustrates a variation of the slidable expansion device.

FIG. 79 illustrates a variation of a method for loading the expandablesupport device of FIG. 10 onto the slidable expansion device of FIG. 78.

FIGS. 80 and 81 illustrate a variation of a method for using theslidable expansion device.

FIG. 82 illustrates a variation of a method for using the slidableexpansion device.

FIG. 83 illustrates a variation of a method for using the slidableexpansion device.

FIGS. 84 and 85 show side and front views, respectively, of a variationof the expansion component.

FIGS. 86 and 87 show side and front views, respectively, of a variationof a method for using the variation of the expansion component of FIGS.84 and 85.

FIGS. 88 and 89 show side and front views, respectively, of a variationof the expansion component.

FIGS. 90 and 91 show side and front views, respectively, of a variationof a method for using the variation of the expansion component of FIGS.88 and 89.

FIGS. 92 and 93 show side and front views, respectively, of a variationof the expansion component.

FIGS. 94 and 95 show side and front views, respectively, of a variationof a method for using the variation of the expansion component of FIGS.92 and 93.

FIGS. 96 and 97 show side and front views, respectively, of a variationof the expansion component.

FIGS. 98 and 99 show side and front views, respectively, of a variationof a method for using the variation of the expansion component of FIGS.96 and 97.

FIGS. 100 and 101 show side and front views, respectively, of avariation of the expansion component.

FIGS. 102 and 103 show side and front views, respectively, of avariation of a method for using the variation of the expansion componentof FIGS. 100 and 101.

FIGS. 104 and 105 illustrate a variation of the expansion component anda variation of a method for using the expansion component.

FIGS. 106 and 107 illustrate a variation of a deployment tool.

FIGS. 108 through 110 illustrate a variation of a method of expandingthe expandable support device using the deployment tool of FIGS. 106 and107.

FIGS. 111 and 112 are schematic illustrations of the forces acting onthe expandable support device as illustrated in FIGS. 108-110.

FIGS. 113 and 114 illustrate a variation of the expandable supportdevice in an expanded configuration.

FIGS. 115 and 116 illustrate a variation of a method for deploying theexpandable support device into the damage site in the vertebra.

FIG. 117 illustrates a variation of a method for deploying a secondexpandable support device or locking pin in the damage site in thevertebra.

FIGS. 118 through 120 illustrate a method for deploying a secondexpandable support device in the vertebra.

FIG. 121 is a close-up view of a variation of section A-A of FIG. 120.

FIG. 122 illustrates a variation of a buttress.

FIGS. 123 through 125 illustrate variations of section B-B of thebuttress of FIG. 122.

FIGS. 126 through 128 illustrate a variation of a method for deploying abuttress.

FIG. 129 illustrates a variation of a method for deploying a buttress.

FIGS. 130 through 132 illustrate a variation of a method for deploying abuttress

FIG. 133 illustrates a variation of a buttress.

FIG. 134 illustrates a variation of section C-C of the buttress of FIG.133.

FIG. 135 illustrates a variation of a method for deploying a buttress.

FIGS. 136 through 139 illustrate a method for deploying the expandablesupport device of FIGS. 17 through 20.

FIGS. 140 through 142 illustrate a method for deploying the expandablesupport device of FIGS. 31 through 34.

FIG. 143 illustrates the deployed expandable support device of FIGS. 31through 34 in use.

FIGS. 144 and 145 illustrate a method for deploying the expandablesupport device of FIGS. 35 and 36.

FIG. 146 illustrates a method of using the expandable support device ofFIGS. 31 through 34 with the band.

FIG. 147 through 149 illustrate variations of a locking pin.

DETAILED DESCRIPTION

FIG. 1 illustrates an expandable support device 2, such as a stent, thatcan be implanted in a bone, such as a compression fracture in avertebra, in the intervertebral space between two vertebrae, or in softtissue, such as a herniated intervertebral disc. The expandable supportdevice 2 should be biocompatible. The expandable support device 2 canhave one of many configurations, and can be used, for example, formethods of repairing vertebral bone fractures or supporting adjacentvertebral bodies for fusion. The expandable support device 2 can have afirst end 4 and a second end 6.

FIG. 2 illustrates that the expandable support device 2 can have a wall8. The wall 8 can have struts 10. The struts 10 can vary in densityalong the length of the expandable support device 2 from the first end 4to the second end 6. The density of the struts 10 can be higher near thefirst end 4 than near the second end 6 (as shown). The density of thestruts 10 can be higher near the second end 6 than near the first end 4.The density of the struts 10 can be higher near the first end 4 and thesecond end 6 than the middle between the first 4 and second ends 6.Controlling the density, thickness and arrangement of the struts resultsin controlled deployment and shape of the implant.

FIG. 3 illustrates that the expandable support device 2 can have atapered configuration before or after deployment. The first end 4 canhave a first diameter 12. The second end 6 can have a second diameter14. The second diameter 14 can be greater than the first diameter 12 (asshown). The first diameter 12 can be greater than the second diameter14. The first diameter 12 and second diameters 14 can both be greaterthan a diameter in the middle of the expandable support device 2 betweenthe first end 4 and second end 6. The tapered configuration can be aresult of a greater strength of the expandable support device 2 at ornear the tapered section or end of the expandable support device 2. Agreater density of struts 10 can be at the first end 4 to achieve thisresult. The struts 10 at the first end 4 can have a greater strutdiameter than the struts 10 at the second end 6. The expandable supportdevice 2 can have a first port 16 at the first end 4. The expandablesupport device 2 can have a second port 18 at the second end 6.

FIG. 4 illustrates that the device in cross-section A-A can have avarying wall thickness 20 along a longitudinal length of the expandablesupport device 2 from the first end 4 to the second end 6. The wallthickness 20 can be greater at the first 4 and second ends 6 than in themiddle of the expandable support device 2 between the first 4 and secondends 6.

FIG. 5 illustrates that the wall 8 can be made from struts 10. The strutdiameters 22 can vary along the length of the expandable support device2. FIG. 5 illustrates the strut diameters 22 can be greater at the first4 and second ends 6 than the strut diameters 22 between the first 4 andsecond ends 6. FIG. 6 illustrates that the strut diameters 22 can begreater at the second end 6 than the strut diameters 22 at the first end4. The strength of the wall 8 can be adjusted along the length of theexpandable support device 2 by designing varying, for example, strutdiameters 22, strut cross-sectional areas, strut densities (i.e., strutspacing, number of struts), strut cross-sectional geometries, andcombinations thereof.

FIG. 7 illustrates that the expandable support device 2 can have abullet shape. The wall 8 can have a first radius of curvature 24 near orat the first end 4. The first end 4 can have a first rim 26circumferentially around the first end 4. The wall 8 can have a secondradius of curvature 28 near or at the second end 6. The first radius ofcurvature 24 can be less than the second radius of curvature 28 (asshown). The first radius of curvature 24 can be greater than the secondradius of curvature 28. The first and second radii of curvature can begreater than a radius of curvature between the first 4 and second ends6.

FIG. 8 illustrates that the expandable support device 2 can be sharplypointed at the first end 4 (as shown), and/or second end 6. The firstend 4 can have a smaller first port 16 than the second port 18, or nofirst port 16 (as shown). The first end 4 can be made from, for example,a plastic and/or dense mesh of thick wires.

FIG. 9 illustrates that the expandable support device 2 can have athread 34. The expandable support device 2 can be rotated duringimplantation to screw into an implant site, such as a vertebra.

FIG. 10 illustrates an expandable support device 2 that can have anengagement groove 36. The engagement groove 36 can be on the innerdiameter of the expandable support device 2. The engagement groove 36can be configured to engage the external engagement thread on theexpansion component.

FIG. 11 illustrates a twistable coil variation of the expandable supportdevice 2 in an untwisted configuration. The untwisted expandable supportdevice 2 can have a contracted diameter 38. The contracted diameter 38can be less than the expanded diameter of the twistable coil variationof the expandable support device 2. The coils can be resiliently ordeformably altered in configuration during untwisting. The coils canresiliently expand when released from the untwisted configuration.

FIG. 12 illustrates that multiple expandable support devices 2 can eachhave an outer diameter and an inner diameter in a relaxed configuration.The first expandable support device 40 can have a first device outerdiameter 42 that can be equal to or greater, for example by asubstantially small amount, than a second device inner diameter 44. Thesecond expandable support device 46 can have a second device outerdiameter 48 that can be equal to or greater, for example by asubstantially small amount, than a third device inner diameter 50. Thefirst device 40 can have a first device inner diameter 52 and the thirddevice 54 can have a third device outer diameter 56.

As shown in FIGS. 12 and 13, the third expandable support device 54 canbe deployed. The second expandable support device 46 can then beinserted 58 into the third expandable support device 54. The secondexpandable support device 46 can then be expanded 60 in the thirdexpandable support device 54.

As shown in FIGS. 12 and 14, the first expandable support device 40 canthen be inserted 62 into the second expandable support device 46. Thefirst expandable support device 40 can then be expanded 64 into thesecond expandable support device 46. The concentrically smallerexpandable support devices 2 can butt against the next larger expandablesupport devices 2 (the gap shown in FIG. 14 between the third and secondexpandable support devices 54 and 46, respectively, is for illustrativepurposes). As shown in greater detail below, each expandable supportdevice 2 can support, and/or substantially lock into place, the nextlarger, abutting, expandable support device 2.

FIGS. 15 and 16 illustrate an expandable support device 2 that can havea first wedge 66 and a second wedge 68, such as the buttress of FIGS.133 through 135, supra, of which any characteristic, feature, orfunctionality can be used for the expandable support device 2 describedherein. A first wedge force 70 can be applied to the first wedge 66. Asecond wedge force 72 can be applied to the second wedge 68. The firstwedge 66 can translate in the direction of arrow 74, as shown. Thesecond wedge 68 can translate in the direction of arrow 76, as shown.FIG. 16 illustrates that the expandable support device 2 can have alarger, expanded diameter 78 after the first 70 and second wedge forces72 have been applied.

FIGS. 17 through 20 illustrate a variation of a biocompatible implantthat can be used for tissue repair, for example for repair bonefractures such as spinal compression fractures, and/or repairing softtissue damage, such as herniated vertebral discs and/or anintervertebral/interspinous spacer or fusion device. The implant can bean expandable support device 2, for example a stent. The expandablesupport device 2 can have a longitudinal axis 80. The expandable supportdevice 2 can have an elongated wall 8 around the longitudinal axis 80.The expandable support device 2 can have a substantially and/orcompletely hollow longitudinal port 82 along the longitudinal axis 80.

The wall 8 can have one or more first struts 84. The first struts 84 canbe configured to be deformable and/or expandable. The wall 8 can havecan have one or more second struts 86. The second struts 86 can besubstantially undeformable and substantially inflexible. The firststruts 84 can be flexibly (e.g., deformably rotatably) attached to thesecond struts 86.

The wall 8 can be configured to expand radially away from thelongitudinal axis 80, for example in two opposite radial directions. Afirst set of first struts 84 can be aligned parallel to each other withrespect to the longitudinal axis 80. A second set of first struts 80 canbe aligned parallel to each other with respect to the longitudinal axis80. The second set of first struts 84 can be on the opposite side of thelongitudinal axis 80 from the first set of first struts 84. The secondstruts 86 can attach any or all sets of first struts 84 to other sets offirst struts 84.

The second struts 86 can have one or more ingrowth ports 88. Theingrowth ports 88 can be configured to encourage biological tissueingrowth therethrough during use in order to aid in fixing theexpandable support device in place and/or promote fusion of adjacentbone structures, either within the same bone (e.g., for vertebroplastyor kyphoplasty) or between adjacent bone structures (e.g., betweenadjacent vertebral bodies to promote fusion). The ingrowth ports 88 canbe configured to releasably and/or fixedly attach to a deployment toolor other tool. The ingrowth ports 88 can be configured to increase,and/or decrease, and/or focus pressure against the surroundingbiological tissue during use. The ingrowth ports 88 can be configured toincrease and/or decrease the stiffness of the second struts 86. Theingrowth ports 88 can be configured to receive and/or attach to abuttress.

The first struts 84 can be configured to have a “V” shape. The spacebetween adjacent first struts 84 can be configured to receive and/orattach to a locking pin during use.

The wall 8 can have a wall thickness 20. The wall thickness 20 can befrom about 0.25 mm (0.098 in.) to about 0.5 mm (0.2 in.), for exampleabout 1 mm (0.04 in.). The wall 8 can have an inner diameter 90. Theinner diameter 90 can be from about 1 mm (0.04 in.) to about 30 mm (1.2in.), for example about 6 mm (0.2 in.). The wall thickness 20 and/or theinner diameter 90 can vary with respect to the length along thelongitudinal axis 80. The wall thickness 20 and/or the inner diameter 90can vary with respect to the angle formed with a plane parallel to thelongitudinal axis 80. The expandable support device may have anexpansion ratio (i.e., the ratio of the unexpanded diameter to theexpanded diameter) of from about 1:2 to about 1:5 or greater, dependingupon the application. For vertebroplasty and intervertebral spacing theexpansion ratio is preferably about 1:3 to about 1:4.

FIGS. 21 through 23 illustrate another variation of an expandablesupport device 2 that can be configured to expand away from thelongitudinal axis 80 in more than two opposite directions, for examplein two sets of opposite radial directions. The wall 8 can have four setsof first struts 84. Each set of first struts 84 can be opposite toanother set of first struts 84. Each of four sets of second struts 86can attach each set of first struts 84. Providing four orthogonallyoriented sets of first struts 10 permits expansion in two orthogonalplanes, which advantageously may be considered height and widthdirections. In the case of an intervertebral implant, for example, suchexpansion in two directions permits height expansion to engage andsupport adjacent vertebral bodies and width expansion to increase thewidth of the surface contact area or “footprint” of engagement betweenthe implant and the adjacent vertebrae. The implant may be filled withbone growth promoting substances (e.g., autologous bone, allograft bone,bone extenders, bone growth factors, bone morphogenic proteins, stemcells, carriers for any of them, and mixtures of any of them or withother suitable substances) to promote bone growth into and through thespace.

The first struts 84 on a first longitudinal half of the expandablesupport device 2 can be oriented (e.g., the direction of the pointed endof the “V” shape) in the opposite direction as the first struts 84 on asecond longitudinal half of the expandable support device 2. See FIGS.21-22. Orienting the first struts 84 in opposite directions permitscontrolled expansion of the expandable support device 2 such that theoverall length of the expandable support device 2 can be conservedduring and after expansion, with minimal longitudinal displacement ofradially opposed sides of the expandable support device 2.

FIGS. 24 and 25 illustrate that the longitudinal port 82 can have one ormore lock grooves 92. The lock grooves 92 can be configured to receiveand/or slidably and fixedly or releasably attach to a locking pin orbuttress. As explained in greater detail below, the locking pin orbuttress may be an insertable structure separate from the expandablesupport device 2 or may be preassembled to the expandable support device2 or may be integrally formed with the expandable support device 2.

FIG. 26 illustrates a visually flattened pattern of the wall 8 foranother variation of the expandable support device 2. (The pattern ofthe wall 8 can be flattened for illustrative purposes only, or the wall8 can be cut in a flattened state and welded or otherwise secured into athree dimensional shape during the manufacturing process.) The patterncan have multiple configurations for the first and/or second struts 84and/or 86. For example, first struts 84 can have a first configuration84 a (e.g., a “V” shape in oppositely oriented sets) and first struts 84can have a second configuration 84 b (e.g., a “U” shape in oppositelyoriented sets. In FIG. 26, second struts 12 are relatively narrowbetween the sets of first struts).

FIGS. 27 and 28 illustrate that that rather than the generally circularor oval cross sectional shape of prior variations, the expandablesupport device 2 can have a square or, rectangular cross-sectionalconfiguration. As shown, the square or rectangular configuration caninclude features such as grooves 20 to receive one or more locking pinsor buttresses, as contemplated herein.

FIGS. 29 and 30 illustrate that the expandable support device 2 can haveprotruding tissue engagement elements, such as tissue hooks, and/orbarbs, and/or cleats 94 (referred to herein as cleats 94). The cleats 94can be integral with and/or fixedly or removably attached to the firstand/or second struts 86. The cleats 94 can be on substantially oppositesides of the expandable support device 2. As will be appreciated, as theexpandable support device 2 can be expanded the tissue engagementelements will engage adjacent tissue, e.g., adjacent vertebral bodies inthe case of an intervertebral spacer, to help secure the device in placerelative to adjacent structures.

FIGS. 31 through 34 illustrate that the expandable support device 2 canhave panels attached to other panels at flexible joints. The expandablesupport device 2 can have first panels 96 attached to and/or integralwith second panels 98 at first joints 100. The second panels 98 can beattached to and/or integral with third panels 102 at second joints 104.The expandable support device 2 can have one or more tool engagementports 106, for example on the first panels 96. The expandable supportdevice 2 can have one or more ingrowth ports 88, for example, on thethird panels 102. The outside of the first panel 96 can be concave.

FIGS. 35 and 36 illustrate that the expandable support device 2 can havefirst and/or second struts 84, 86 and/or and panels 96, 98. The firstand/or second struts 84, 86 can be internal to the panels 96, 98. Thefirst struts 84 can be attached to the third panels 102.

The expandable support device 2 can have a radius of curvature along thelongitudinal axis 80. The radius of curvature can be from about 1 mm(0.04 in.) to about 250 mm (10 in.), for example about 50 mm (2 in.).(The wall 8 is shown sans panels or struts for illustrative purposes.)The expandable support device 2 can have at least one flat side, forexample two flat sides. The two flat sides can be on opposite sides ofthe expandable support device 2 from each other. In the variation shownin FIGS. 35-36, the internal first strut 84 can help provide controlledexpansion of the device and internal support to the expanded device.

FIGS. 37 through 41 illustrate an expandable support device 2, that canbe implanted in a bone, such as a compression fracture in a vertebra, orin soft tissue, such as a herniated intervertebral disc, or interspinousligament. The expandable support device 2 should be biocompatible. Theexpandable support device 2 can be used for tissue repair, for examplefor repair bone fractures such as spinal compression fractures, and/orrepairing soft tissue damage, such as herniated vertebral discs offusion or fixation.

The expandable support device 2 can have a longitudinal axis 80. Theexpandable support device 2 can have a first end 4 and a second end 6.The first end 4 can be substantially parallel with the second end 6. Thefirst end 4 may be displaced from the longitudinal axis 80 by a firstangle 108 and the second end may be displaced from the longitudinal axis80 by a second angle 110 when the expandable support device 2 is in acontracted configuration (as shown). The expandable support device 2 canbe hollow, for example along the longitudinal axis 80. The first end 4can have a first port 16. The second end 6 can have a second port 18.The first angle 108 can be substantially equal to the second angle 110.The angles 108, 110 can be from about 0° to about 90°, more narrowlyfrom about 5° to about 45°, yet more narrowly from about 10° to about30°, for example about 20°.

The expandable support device 2 can have a wall 8. The outer and/orinner surfaces of the wall 8 can be configured to increase friction orbe capable of an interference fit with another object, such as a secondexpandable support device 46. The configurations to increase friction orbe capable of an interference fit include teeth, knurling, coating, orcombinations thereof.

The wall 8 can have struts 10. By way of example only, the wall 8 canhave about 8 struts 10 on each side of the expandable support device 2.The struts 10 can be substantially parallel to the slanted configurationof the angled first end 4 and/or second end 6. The struts 10 can beseparated from the other struts 10 by wall openings 112. The expandablesupport device 2 can have about 7 wall openings 112 on each side. Thewall openings 112 can be substantially parallel to the first end 4and/or second end 6, for example when the expandable support device 2 isin a contracted configuration. The expandable support device 2 can haveingrowth ports 88.

The expandable support device 2 can have a first port 16 and/or a secondport 18. A hollow of the expandable support device 2 can be completelyor partially coated and/or filled with agents and/or a matrix as listedbelow.

The leading end of the expandable support device 2 can be sharpened. Theleading end can be used to help move tissue aside during implantationand deployment. The leading end can be self-penetrating.

When in a contracted configuration, the expandable support device 2 canhave a contracted length 114 (i.e., the length when the expandablesupport device is in a radially contracted configuration) and acontracted height 116. By way of example only, the contracted length 114can be from about 0.318 cm (0.125 in.) to about 10 cm (4 in.), forexample about 3.8 cm (1.5 in). The contracted height 116 can be fromabout 0.1 cm (0.05 in.) to about 3 cm (1 in.), for example about 0.8 cm(0.3 in.).

FIG. 42 illustrates that the expandable support device 2 can haveshorter struts 10 than the struts shown in FIGS. 37 through 41. By theway of example only, the length of the struts 10 can be from about 0.3cm (0.1 in.) to about 5 cm (2 in.), for example about 2 cm (0.7 in.),also for example about 1 cm (0.5 in.).

FIG. 43 illustrates that the expandable support device 2 can have fromrelatively few struts 10. It is contemplated that the expandable supportdevice 2 may have from about 2 struts to about 50 struts 10. About 4struts 10 to about 8 struts 10 may be suitable for many applications.The expandable support device 2 can have from about 1 wall opening 112to about 51 wall openings 112, for example about 3 wall openings 112,also for example about 7 wall openings 112.

FIG. 44 illustrates that the expandable support device 2 can have afirst pane 118, a second pane 120, a third pane 122, and a fourth pane124. A first joint 100 can attach the first pane 118 to the second pane120. A second joint 104 can attach the second pane 120 to the third pane122. A third joint 126 can attach the third pane 122 to the fourth pane124. The joints can rotatably attach the panes. The joints can beseparate from or integral with the panes. Each pane can have struts 10and wall openings 112. During use, the joints can enable the panes torotate in-plane, as shown by arrows 128.

FIGS. 45, 46 and 47 illustrate that the expandable support device 2, canhave for example a square or rectangular, circular, or polygonalcross-section, respectively. FIG. 47 shows the joints as contemplatedabove in the description of FIG. 44 as nodes having a wider section thanthe wall 8, but the joints can also have the same width or a smallerwidth than the wall 8.

FIGS. 48 through 50 illustrate that the expandable support device 2 canhave a radius of curvature 130 along the longitudinal axis 80. Theradius of curvature 130 can be from about 1 mm (0.04 in.) to about 250mm (10 in.), for example about 50 mm (2 in.). The wall 8 is shownwithout panels or struts 10 for illustrative purposes, but it will beunderstood that the initial configuration and deployment force andmethod can influence the shape of the deployed implant. The expandablesupport device 2 can have at least one flat side, for example two flatsides. The two flat sides can be on opposite sides of the expandablesupport device 2 from each other.

The expandable support devices 2 can have textured and/or poroussurfaces for example, to increase friction against bone surfaces, and/orpromote tissue ingrowth. The expandable support devices 2 can be coatedwith a bone growth factor, such as a calcium base.

The expandable support device 2 can be covered by a thin metal screen.The thin metal screen can expand and/or open when the expandable supportdevice 2 expands.

Any or all elements of the expandable support device 2 and/or otherdevices or apparatuses described herein can be made from, for example, asingle or multiple stainless steel alloys, nickel titanium alloys (e.g.,Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin SpecialtyMetals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp.,Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N®, from MagellanIndustrial Trading Company, Inc., Westport, Conn.), molybdenum alloys(e.g., molybdenum TZM alloy, for example as disclosed in InternationalPub. No. WO 03/082363 A2, published 9 Oct. 2003, which is hereinincorporated by reference in its entirety), tungsten-rhenium alloys, forexample, as disclosed in International Pub. No. WO 03/082363, polymerssuch as polyethylene teraphathalate (PET)/polyester (e.g., DACRON® fromE. I. Du. Pont de Nemours and Company, Wilmington, Del.), polypropylene,(PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyetherketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone(PEKK) (also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),polyurethane, thermoplastic, fluorinated ethylene propylene (FEP),absorbable or resorbable polymers such as polyglycolic acid (PGA),polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA),polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extrudedcollagen, silicone, zinc, echogenic, radioactive, radiopaque materials,a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone) any of the other materials listed herein or combinations thereof.Examples of radiopaque materials are barium sulfate, zinc oxide,titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

Any or all elements of the expandable support device 2 and/or otherdevices or apparatuses described herein, can be, have, and/or becompletely or partially coated with agents and/or a matrix a matrix forcell ingrowth or used with a fabric, for example a covering (not shown)that acts as a matrix for cell ingrowth. The matrix and/or fabric canbe, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemoursand Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon,extruded collagen, silicone or combinations thereof.

The expandable support device 2 and/or elements of the expandablesupport device 2 and/or other devices or apparatuses described hereinand/or the fabric can be filled, coated, layered and/or otherwise madewith and/or from cements, fillers, glues, and/or an agent deliverymatrix known to one having ordinary skill in the art and/or atherapeutic and/or diagnostic agent. Any of these cements and/or fillersand/or glues can be osteogenic and osteoinductive growth factors.

Examples of such cements and/or fillers includes bone chips,demineralized bone matrix (DBM), calcium sulfate, corallinhydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate,polymethyl methacrylate (PMMA), biodegradable ceramics, bioactiveglasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs)such as recombinant human bone morphogenetic proteins (rhBMPs), othermaterials described herein, or combinations thereof.

The agents within these matrices can include any agent disclosed hereinor combinations thereof, including radioactive materials; radiopaquematerials; cytogenic agents; cytotoxic agents; cytostatic agents;thrombogenic agents, for example polyurethane, cellulose acetate polymermixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious,hydrophilic materials; phosphor cholene; anti-inflammatory agents, forexample non-steroidal anti-inflammatories (NSAIDs) such ascyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, forexample ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, forexample ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamicacid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., WhitehouseStation, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®,from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP)inhibitors (e.g., tetracycline and tetracycline derivatives) that actearly within the pathways of an inflammatory response. Examples of otheragents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999,48-54; Tambiah et al, Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940;Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and ItsEffect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6),771-775; Xu et al, Spl Increases Expression of Cyclooxygenase-2 inHypoxic Vascular Endothelium, J. Biological Chemistty 275 (32)24583-24589; and Pyo et al, Targeted Gene Disruption of MatrixMetalloproteinase-9 (Gelatinase B) Suppresses Development ofExperimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105(11), 1641-1649 which are all incorporated by reference in theirentireties.

The expandable support devices 2 can be laser cut, machined, cut by wireelectrical discharge machining (“EDM”) or made by other suitabletechniques. The expandable support device 2 can be cut in a fullycontracted or unexpanded configuration or may be cut in a partiallyopened pattern, then loaded (e.g., crimped) onto a deployment tool 132(e.g., balloon 134). The loaded expandable support device 2 can have asmaller profile while plastically deforming the struts 10 past theirlimits.

The expandable support device 2 can be longitudinally segmented.Multiple expandable support devices 2 can be attached first end 4 tosecond end 6, and/or a single expandable support device 2 can be severedlongitudinally into multiple expandable support devices 2.

Method of Use

FIG. 51 illustrates that the expandable support device 2 can be loadedin a collapsed (i.e., contracted) configuration onto a deployment tool132. The deployment tool 132 can have an expandable balloon 134 catheter136 as known to those having an ordinary level of skill in the art. Thecatheter 136 can have a fluid conduit 138. The fluid conduit 138 can bein fluid communication with balloon 134. The balloon 134 and thedeployment tool 132 can be the balloon 134 and deployment tool 132described in PCT Application No. US2005/033,965, Publication No. WO2006/034,396, filed 21 Sep. 2005 entitled “Balloon and Methods of Makingand Using.” The balloon 134 can be configured to receive a fluidpressure of at least about 5,000 kPa (50 atm), more narrowly at leastabout 10,000 kPa (100 atm), for example at least about 14,000 kPa (140atm).

Alternatively, the deployment tool 132 can be a pair of wedges, anexpandable jack, other expansion tools, or combinations thereof.

FIG. 52 illustrates that the fluid pressure in the fluid conduit 138 andballoon 134 can increase, thereby inflating the balloon 134, as shown byarrows. The expandable support device 2 can expand, for example, due topressure from the balloon 134.

FIGS. 53 (side view) and 54 (top view) illustrate a vertebral column 140that can have one or more vertebra 142 separated from the other vertebra142 by discs 144. The vertebra 142 can have a damage site 146, forexample a compression fracture.

An access tool 148 can be used to gain access to the damage site 146 andor increase the size of the damage site 146 to allow deployment of theexpandable support device 2. The access tool 148 can be a rotating orvibrating drill 150 that can have a handle 152. Optionally, the drill150 may oscillate, as shown by arrows 154. The drill 150 can then betranslated, as shown by arrow 156, toward and into the vertebra 142 soas to pass into the damage site 146.

FIG. 55 illustrates that the access tool 148 can be translated, as shownby arrow 158, to remove tissue at the damage site 146. The access tool148 can create an access port 160 at the surface of the vertebra 142.The access port 160 can open to the damage site 146. The access tool 148can then be removed from the vertebra 142.

FIG. 56 illustrates that a first deployment tool 162 can enterposteriorly through the subject's back. The first deployment tool 162can enter through a first incision 164 in the skin 166 on the posteriorside 167 of the subject near the vertebral column 140. The firstdeployment tool 162 can be translated, as shown by arrow 168, toposition a first expandable support device 40 into a first damage site170. The first access port 172 can be on the posterior side 167 of thevertebra 142.

A second deployment tool 174 can enter through a second incision 176 (asshown) in the skin 166. The second incision 176 may be posterior (asshown) or may be anterior, lateral, posterior lateral, or the like. Thesecond deployment tool 174 can be translated through muscle (not shown),around nerves 178, the spinal cord 180, and anterior 182 of thevertebral column 140. The second deployment tool 174 can be steerable.The second deployment tool 174 can be steered, as shown by arrow 184, toalign the distal tip of the second expandable support device 46 with asecond access port 186 on a second damage site 188. The second accessport 186 can face anteriorly 182. The second deployment tool 174 cantranslate, as shown by arrow 190, to position the second expandablesupport device 46 in the second damage site 188.

As illustrated, the vertebra 142 can have multiple damage sites andexpandable support devices deployed therein. The expandable supportdevices can be deployed from the anterior 182, posterior 167, bothlateral, superior, inferior, any angle, or combinations of thedirections thereof. Of course, a single device may be deployed from onedirection rather than multiple devices from multiple directions.

FIGS. 57 and 58 illustrate translating, as shown by arrow, thedeployment tool 132 loaded with the expandable support device 2 throughthe access port 160 from the anterior side 182 of the vertebral column140. FIGS. 59 and 60 illustrate that the deployment tool 132 can bedeployed from the posterior side 167 of the vertebral column 140. Thedeployment tool 132 can be deployed off-center, for example, whenapproaching the posterior side 167 of the vertebral column 140.

FIG. 61 illustrates that deployment tool 132 can position the expandablesupport device 2 in the vertebra 142 and into the damage site 146.

FIG. 62 illustrates that the fluid pressure in the fluid conduit 136 andthe balloon 134 can increase, thereby inflating the balloon 134, asshown by arrows. The expandable support device 2 can expand, forexample, due to pressure from the balloon 134. The balloon 134 can beexpanded until the expandable support device 2 is substantially fixed tothe vertebra 142. The balloon 134 and/or the expandable support device 2can reshape the vertebral column 140 to a more natural configurationduring expansion of the device.

FIGS. 63 and 64 illustrate that first and second deployment tools 162and 174 can position and deploy first and second expandable supportdevices 40 and 46 simultaneously, and/or in the same vertebra 142 andinto the same or different damage sites 170 and 188.

FIG. 65 illustrates that the fluid pressure in the fluid conduit 138 andthe balloon 134 can increase, thereby inflating the balloon 134, asshown by arrows. The expandable support device 2 can expand, forexample, due to pressure from the balloon 134. The balloon 134 can beexpanded until the expandable support device 2 is substantially fixed tothe vertebra 142. The balloon 134 and/or the expandable support device 2can reshape the vertebral column 140 to a more natural configurationduring expansion of the balloon 134.

FIG. 66 illustrates that the access port 160 can be made close to thedisc 144, for example when the damage site 146 is close to the disc 144.The deployment tool 132 can be inserted through the access port 160 andthe expandable support device 2 can be deployed as described supra.

FIG. 67, a front view of the vertebral column 140, illustrates that morethan one expandable support device 2 can be deployed into a singlevertebra 142. For example, a first expandable support device (not shown)can be inserted through a first access port 172 and deployed in a firstdamage site 170, and a second expandable support device (not shown) canbe inserted through a first access port 172 and deployed in a seconddamage site 188.

The first access port 172 can be substantially centered with respect tothe first damage site 170. The first expandable support device (notshown) can expand, as shown by arrows 64, substantiallyequidirectionally, aligned with the center of the first access port 172.The second access port 186 can be substantially not centered withrespect to the second damage site 188. The second expandable supportdevice (not shown) can substantially anchor to a side of the damage site146 and/or the surface of the disc 144, and then expand, as shown byarrows 60, substantially directionally away from the disc 144.

FIG. 68 illustrates that the fluid pressure can be released from theballoon 134, and the balloon 134 can return to a pre-deploymentconfiguration, leaving the expandable support element substantiallyfixed to the vertebra 142 at the damage site 146.

The access port 160 can have an access port diameter 192. The accessport diameter 192 can be from about 1.5 mm (0.060 in.) to about 40 mm (2in.), for example about 8 mm (0.3 in.). The access port diameter 192 canbe a result of the size of the access tool 148 and in the unexpandedexpandable support device 2. After the expandable support device 2 isdeployed, the damage site 146 can have a deployed diameter 194. Thedeployed diameter 194 can be from about 1.5 mm (0.060 in.) to about 120mm (4.7 in.), for example from about 10 mm (0.4 in.) to about 20 mm (0.8in.), or from about 12 mm (0.47 in.) to about 16 mm (0.63 in.). Thedeployed diameter 194 can be greater than, equal to, or less than theaccess port diameter 192.

FIG. 69 illustrates that the deployment tool 132 can be removed, asshown, from the vertebra 142 after the expandable support device 2 isdeployed.

FIGS. 70 and 71 illustrate that a locking pin 196 can be inserted, asshown by arrow, into the deployed expandable support device 2, forexample, after the expandable support device 2 is deployed in thevertebra 142. The locking pin 196 can prevent the expandable supportdevice 2 from collapsing after the expandable support device 2 isdeployed in the vertebra 142. The locking pin 196 can form aninterference fit with the expandable support device 2 or may includefeatures to hold the locking pin in place.

The locking pin 196 can be parallel with the longitudinal axis 80, asshown in FIG. 72, for example when the locking pin 196 is slidablyreceived by and/or attached to the lock grooves 92 (see for example,FIG. 25). The locking pin 196 can be perpendicular to the longitudinalaxis 80, as shown in FIG. 71, for example when the locking pin 196 isslidably received by and/or attached to ports formed between adjacentfirst struts 84 after the expandable support device 2 is expanded.

FIGS. 72 through 77 illustrate various methods for deploying the lockingpin 196 into the expandable support device 2. As shown in FIGS. 72 and73, the locking pin 196 can be translated, as shown by arrow, into theexpandable support device 2 along the implant longitudinal axis. Asshown in FIG. 74, a first end of the locking pin 196 can be translated,as shown by arrow, at an oblique angle, into a first port 16 formedbetween adjacent first struts 84. As shown by FIG. 75, a second end ofthe locking pin 196 can be rotated, as shown by arrow. As shown by FIG.76, the second end of the locking pin 196 can be translated, as shown byarrow, into a second port 18 formed between adjacent first struts 84.FIG. 77 shows the locking pin 196 deployed into, and forming aninterference fit with, the expandable support device 2.

FIG. 78 illustrates a slidable expansion device 198. The slidableexpansion device 198 can have an expansion component 200, a deploymentextension 202, a handle 204, or combinations thereof. The expansioncomponent 200 can be configured to radially and/or longitudinallyexpand. The expansion component 200 can expand directly against tissueand/or expand an implant pre-loaded into the deployment site, and/orloaded onto or into the expansion component 200.

The expansion component 200 can have a first slidable element 206 and asecond slidable element 208. The first and second slidable elements 206and 208 can be configured to slide relative to each other. An interface210 can be provided between the first slidable element 206 and thesecond slidable element 208. The expansion component 200 optionally canhave an engagement element, such as an external engagement rib or thread212. The external engagement thread 212 can spiral around the expansioncomponent 200. The interface 210 can intersect the external engagementthread 212.

The deployment extension 202 can have a first extension arm 214 and asecond extension arm 216. The first extension arm 214 can be fixedlyattached to a third fixed element, such as the handle 204. The firstextension arm 214 can be fixedly attached to the expansion component200. The first extension arm 214 can maintain a substantially constantdistance between the handle 204 and the first slidable element 206. Thesecond extension arm 216 can be fixedly attached to the slidableexpansion device 198 and slidably attached to the third fixed element,such as the handle 204.

The angle between an extension arm longitudinal axis 218, such as anaxis extending along the second extension arm 216, and the interface 210can form an expansion angle 220. The expansion angle 220 can be fromabout 0° to about 85°, more narrowly from about 10° to about 45°, forexample about 30°.

The handle 204 can have an activation system configured to expand theexpansion component 200. For example, the handle 204 can have a lever222 than can be fixedly or rotatably attached to the second extensionarm 216. The lever 222 can be rotatably attached to a lever pivot 224.The lever pivot 224 can be fixedly attached to a case of the handle 204.A return spring 226 can be attached to the lever 222. The return spring226 can apply a force against the lever 222 sufficient to keep the lever222 against a first stop 228 when the slidable expansion device 198 isnot in use.

FIG. 79 illustrates that the expandable support device 2 can be loadedonto the expansion component 200 of the slidable expansion device 198.The expandable support device 2 can be translated, as shown by arrow230, to the expansion component 200. The optional engagement groove 36can be aligned with and engage the optimal external engagement rib orthread 212, such as by rotating the expandable support device 2, toengage thread and load the expandable support device 2 onto theexpansion component 200.

FIG. 80 illustrates that, when loaded on the slidable expansion device198, the expandable support device 2 (shown in see-through withoutdetails) can have an expandable support device diameter 234.

FIG. 81 illustrates that the lever 222 can be forced to retractablyrotate, as shown by arrow 236, the second extension arm 216. Themovement of the lever 222 can compress the return spring 226. Therotation of the lever 222 can be limited by physical interference at thesecond stop 238. The translation of the second extension arm 216 can, inturn, translate, as shown by arrow 240 the second slidable element 208.As the second slidable element 208 translates along the interface 210,the second slidable element 208 can shift downward (with respect to thepage) and the first slidable element 206 can shift upward, therebycausing expansion, as shown by arrows 242, of the expansion component200 and the expandable support device 2. The expandable support devicediameter 234 can be larger after expansion than before expansion. Thefirst extension arm 214 and/or the second extension arm 216 canresiliently and/or deformably flex during expansion of the expansioncomponent 200.

FIG. 82 illustrates that the first and/or second slidable element 206and/or 208 can have no external engagement thread 212. The first and/orsecond slidable element 206 and/or 208 can be coated or lubricated witha low-friction material, such as TEFLON® (i.e., PTFE) from E. I. Du Pontde Nemours and Company, Wilmington, Del.

FIG. 83 illustrates that the force can be removed from the lever 222.The return spring 226 can translate, as shown by arrow 244. The lever222 can be rotated, as shown by arrow 246, by the return spring 226. Thefirst stop 228 can limit the rotation of the lever 222. The secondextension arm 216 can translate, as shown by arrow 248, the secondslidable element 208. The expansion component 200 can return to acontracted configuration. The expansion component 200 can be removedfrom the then-expanded expandable support device 2. While the deploymentdevice of FIGS. 78-83, for example, shows a pistol type grip with acompressible handle, it also is contemplated that the device could beactuated by a rotational motion about the longitudinal axis of thedeployment component.

FIGS. 84 and 85 illustrate that the expansion component 200 can have asubstantially triangular, or wedge-shaped first and second slidableelements 206 and 208. As discussed above with respect to FIGS. 15 and16, wedge shaped elements 96 and 98 may be incorporated into theexpandable device. Translation of wedges within the device can assist inthe deployment of the expandable device and may provide reinforcementfor the deployed device. In this regard, it is contemplated that thevarious wedge, locking pin or buttress configurations disclosed hereincould aid in deployment and provide rigid support for the expandabledevice. By way of example, wedge configurations as shown in FIGS. 84-99,which may include interlocking, directional teeth or a tongue and grooveinterface as described with regard to the buttress of FIGS. 133-135, maybe included as part of the expandable device. These features can provideexpansion force to the device and added support and rigidity to thedevice in addition to struts 10, 12. The combined effect of the wedgeswith the struts provides the desirable combination of controlledexpansion of the device with balanced counterforces within the device(the wedges opposing the struts and vice versa) so that the device maybe deployed to the desired location and degree of expansion, thecounterforce of the interlocking wedges and the struts establishing auniform structure not prone to release or collapse.

FIGS. 86 and 87 illustrate that a first slidable element force, shown byarrow 250, can be applied to the first slidable element 206 insubstantially the opposite direction as a second slidable element force,shown by arrow 252, can be applied to the second slidable element 208.The first slidable element 206 and the second slidable element 208 cantranslate, as shown by arrows 254 and 248, in opposite directions withrespect to each other parallel to the interface 210 to cause expansion.

FIGS. 88 and 89 illustrate that the expansion component 200 can havesubstantially triangular or wedge-shaped first and second slidableelements 206 and 208. The expansion component 200 can have multiplefirst slidable elements 206 and multiple interfaces 210.

FIGS. 90 and 91 illustrate that a first slidable element force, shown byarrow 250, can be applied to the first slidable elements 206 insubstantially the opposite direction as a second slidable element force,shown by arrow 252, can be applied to the second slidable element 208.The first slidable elements 206 and the second slidable element 208 cantranslate, as shown by arrows 254 and 248.

FIGS. 92 and 93 illustrate that the expansion component 200 can have afirst slidable element 206 that can be flexibly resilient or deformablyand can have a conical port therein. The second slidable element 208 canbe substantially conical and can be positioned in the conical port ofthe first slidable element 206.

FIGS. 94 and 95 illustrate that a first slidable element force, shown byarrow 250, can be applied to the first slidable element 206 insubstantially the opposite direction as a second slidable element force,shown by arrow 252 can be applied to the second slidable element 208.The first slidable element 206 can translate, as shown by arrows 254.The first slidable element 206 can resiliently or deformably expandradially outward.

FIGS. 96 and 97 illustrate that the expansion component 200 can havemultiple first slidable elements 206 that can be flexibly resilient ordeformably and can have a conical port therein. The first slidableelements 206 can be segmented or separated by element separations 148.The element separations 256 can be thinned and very low resistant orcompletely severed areas or lines (as shown). The second slidableelement 208 can be substantially conical and can be positioned in theconical port of the first slidable element 206.

FIGS. 98 and 99 illustrate that first slidable element forces, shown byarrow 250, can be applied to the first slidable elements 206 insubstantially the opposite direction as a second slidable element force,shown by arrow 252, can be applied to the second slidable element 208.The first slidable elements 206 can translate, as shown by arrows 254.The first slidable elements 206 can resiliently or deformably expandradially outward. The first slidable elements 206 can be attached by afilament or thin strip of material (not shown), or can be distinct andunattached to each other.

FIGS. 100 and 101 illustrate that the expansion component 200 can have afirst slidable element 206 that can be rotatably attached to a secondslidable element 208 via a hinge 150. The hinge 258 can rotate about ahinge pin 260 that can pass through the first slidable element 206 andthe second slidable element 208. The second slidable element 208 canhave a cam 262. A camshaft 264 can rotatably attach the cam 262 to thesecond slidable element 208. The cam 262 can be attached to all or partof the deployment extension 202. The cam 262 can be located in adepression or cavity in the second slidable element 208.

FIGS. 102 and 103 illustrate that the deployment extension 202 can betranslated, as shown by arrow 266. This translation can rotate, as shownby arrow 268, the cam 262. The cam 262 can slide along the firstslidable element 206 and can cause the first slidable element 206 torotate, as shown by arrow 254, about the hinge pin 260.

FIG. 104 illustrates that the first slidable element 206 can have aslidable element port 270. The slidable element port 270 can be shaped(e.g., grooved or threaded) to receive the second slidable element 208.The second slidable element 208 can be conical. The second slidableelement 208 can have a slidable element thread 272. The slidable elementport 270 can be threaded. The second slidable element 208 can betranslated, as shown by arrow 248 and rotated, as shown by arrow 274, asthe second slidable element 208 approaches the slidable element port270.

FIG. 105 illustrates that the second slidable element 208 can enter theslidable element port 270. The first slidable element 206 can expand, asshown by arrows 276, as the slidable element port 270 receives thesecond slidable element 208. The slidable element thread 272 can engagethe slidable element port 270. The second slidable element 208 can berotated, as shown by arrows 274, as the second slidable element 208enters the first slidable element 206.

FIG. 106 illustrates an alternative deployment tool 132 can having ashaft 278 and a sleeve 280. The shaft 278 can be slidably received, asshown by arrow, by the sleeve 280. The shaft 278 can have a first catch282. The shaft 278 can have a relief 284 section or an additional catchon a side opposite the first catch 282. The sleeve 280 can have a secondcatch 286.

FIG. 107 illustrates that the deployment tool 132 can have an actuator288, such as an ergonomic lever handle 152. The handle 152 can beattached to the sleeve 280. When the shaft 278 is received in the sleeve280, the actuator 288 can be attached to the shaft 278. Applying a forceto the actuator 288 can cause the shaft 278 to slide or translate in thesleeve 280.

FIG. 108 illustrates that the expandable support device 2, for examplein a contracted configuration, can be loaded on the shaft 278. The firstend 4 of the expandable support device 2 can be received by and/orinterference fit in the first catch 282. The second end 6 of theexpandable support device 2 can be received by and/or interference fitin the relief 284. The first and/or second end 6 of the expandablesupport device 2 can be beveled. The beveled ends can be shaped to fitthe first catch 282 and/or relief 284.

FIG. 109 illustrates that the shaft 278 can slide, as shown by arrow,relative to the sleeve 282. The second end 6 of the expandable supportdevice 2 can be received by and/or engage the second catch 286. Thesecond end 6 can interference fit the second catch 286.

FIG. 110 illustrates that the shaft 278 can be forcibly slid into thesleeve 282 by squeezing the lever handle (see FIG. 107). The expandablesupport device 2 can be squeezed between the first catch 282 and thesecond catch 286. The expandable support device 2 can be resilientlyand/or deformably forced into an expanded configuration. The expandablesupport device 2 can be released from the deployment tool 132, forexample, by releasing the shaft 278 from the handle and sliding theshaft 278 distally through the sleeve 282.

FIG. 111 illustrates that the expandable support device 2 can beexpanded by applying force, as shown by arrows, on the first end 4 andthe second end 6, and by directing the force toward the expandablesupport device 2. FIG. 112 illustrates that the expandable supportdevice 2 can be expanded by applying force, as shown by arrows, radiallyoutward against the wall 8.

FIGS. 113 and 114 illustrate various variations of the expandablesupport device 2 in an expanded configuration. The wall openings 112 canexpand when the expandable support device 2 is in an expandedconfiguration.

The expandable support device 2 can have an expanded height 290 and anexpanded length 292. The expanded height 290 can be from about 0.3 cm(0.1 in.) to about 5 cm (2 in.), for example about 2 cm (0.6 in.). Theexpanded length 292 can be from about 0.1 cm (0.05 in) to about 3.8 cm(1.5 in.), for example about 3 cm (1 in.). The expandable support device2 can have first 294 and second 296 expanded intersection angles. Thefirst expanded intersecting angle 294 can be substantially equal to thesecond expanded intersecting angle 296. The expanded intersecting anglescan be from about 45° to about 135°, for example about 110°, also forexample about 90°.

FIG. 115 illustrates that the fluid pressure can be released from theballoon 134, and the balloon 134 can return to a pre-deploymentconfiguration, leaving the expandable support element substantiallyfixed to the vertebra 142 at the damage site 146.

The access port 160 can have an access port diameter 192. The accessport diameter 192 can be from about 1.5 mm (0.060 in.) to about 40 mm (2in.), for example about 8 mm (0.3 in.). The access port diameter 192 canbe a result of the size of the access tool 148. After the expandablesupport device 2 is deployed, the damage site 146 can have a deployeddiameter 194. The deployed diameter 194 can be from about 1.5 mm (0.060in.) to about 120 mm (4.7 in.), for example about 20 mm (0.8 in.). Thedeployed diameter 194 can be greater than, equal to, or less than theaccess port diameter 192.

FIG. 116 illustrates that the deployment tool 132 can be removed, asshown by arrow, from the vertebra 142 after the expandable supportdevice 2 is deployed.

FIG. 117 illustrate that a second expandable support device 46 and/orlocking pin 196 can be inserted, as shown by arrow 298, into the firstdeployed expandable support device 2, for example, after the firstexpandable support device 40 is deployed in the vertebra 142. The secondexpandable support device 46 and/or locking pin 196 can prevent thefirst expandable support device 40 from collapsing after the firstexpandable support device 40 is deployed in the vertebra 142. The secondexpandable support device 46 and/or locking pin 196 can form aninterference fit with the expandable support device 2.

FIG. 118 illustrates that the second expandable support device 46 can betranslated, as shown by arrow, into the first expandable support device40. The first expandable support device 40 can be in an expanded,contracted, or other configuration. The second expandable support device46 can be in an expanded, contracted, or other configuration. The struts10 and/or wall openings 112 of the first expandable support device 40can be angled in a substantially opposite direction to the struts 10and/or wall openings 112 of the second expandable support device 46.

FIG. 119 illustrates that after the second expandable support device 46is inside the first expandable support device 40, the second expandablesupport device 46 can be subject to any or all of the expansion forces,as shown by arrows.

FIG. 120 illustrates that the second expandable support device 46 can bein an expanded configuration in the first expandable support device 40.The second expandable support device 46 can be translated into the firstexpandable support device 40 and expanded, as shown in FIGS. 118 and119. The second expandable support device 46 can be in an expandedconfiguration and screwed or otherwise attached into the firstexpandable support device 40.

FIG. 121 illustrates that the first expandable support device 40 can berotatably attached to, or have an interference fit with, the secondexpandable support device 46. The first expandable support device 40 canhave first teeth 300, for example on the inside surface of the wall 8.The second expandable support device 46 can have second teeth 302, forexample on the outside surface of the wall 8. The first teeth 300 canengage the second teeth 302.

FIG. 122 illustrates a buttress 304. The buttress 304 can have alongitudinal axis 80. The buttress 304 can have a tensioner 306. A firstend 4 of the tensioner 306 can be fixedly or removably attached a firstend 4 of the buttress 304. A second end 6 of the tensioner 306 can befixedly or removably attached a second end 6 of the buttress 304. Thetensioner 306 can be in a relaxed configuration when the buttress 304 isin a relaxed configuration. The tensioner 306 can create a tensile forcebetween the first end 4 of the buttress 304 and the second end 6 of thebuttress 304 when the buttress 1304 is in a stressed configuration. Thetensioner 306 can be, for example, a resilient wire, a coil, spring, anelastic member, or combinations thereof.

The buttress 304 can have a coil 308. The coil 308 can have turns 310 ofa wire, ribbon, or other coiled element. FIGS. 123 through 125illustrate that the coil 310 can be made from a wire, ribbon, or othercoiled element having a circular, square, or oval cross-section,respectively.

The buttress 304 can be a series of connected hoops.

FIG. 126 illustrates that the buttress 304 can be loaded into a hollowdeployment tool 132 in a smear (i.e., partially shear stressed)configuration at a smear section 310. The buttress 304 in the smearsection 310 can have a relaxed first end 4, a stressed smear section310, and a relaxed second end 6. The longitudinal axis 80 can be notstraight (i.e., non-linear) through the smear section 310.

FIG. 127 illustrates that part of the buttress 304 can be forced, asshown by arrow, out of the deployment tool 132. The second end 6 canexit the deployment tool 132 before the remainder of the buttress 304.The smear section 310 can then partially relax. The second end 6 can bepositioned to a final location before the remainder of the buttress 304is deployed from the deployment tool 132.

FIG. 128 illustrates that the remainder of the buttress 304 can beforced, as shown by arrow, out of the deployment tool 132. The smearsection 310 can substantially relax. The longitudinal axis 80 can returnto a substantially relaxed and/or straight (i.e., linear) configuration.

FIG. 129 illustrates that the buttress 304 can be deployed 312 in theexpandable support device 2, for example with the longitudinal axis 80of the buttress 304 or the strongest orientation of the buttress 304aligned substantially parallel with the primary load bearing direction(e.g., along the axis of the spine) of the expandable support device 2.

FIG. 130 illustrates that the buttress 304 can be loaded into the hollowdeployment tool 132 with the longitudinal axis 80 of the buttress 1304substantially parallel with the hollow length of the deployment tool132. The entire length of the buttress 304 can be under shear stress.

FIG. 131 illustrates that part of the buttress 304 can be forced, asshown by arrow, out of the deployment tool 132. The second end 6 of thebuttress 304 can exit the deployment tool 132 before the remainder ofthe buttress 304. The tensioner 306 can apply a tensile stress betweenthe ends of the buttress 304, for example, forcing the deployed secondend 6 of the buttress 304 to “stand up straight”. The second end 6 ofthe buttress 304 can be positioned to a final location before theremainder of the buttress 304 is deployed from the deployment tool 132.

FIG. 132 illustrates that the remainder of the buttress 304 can beforced, as shown by arrow, out of the deployment tool 132. The buttress304 can substantially relax.

FIG. 133 illustrates that the buttress 304 can have a first wedge 66 anda second wedge 68. The first wedge 66 can contact the second wedge 68 ata directionally locking interface 314. The directionally lockinginterface 314 can have directional teeth 316.

FIG. 134 illustrates that the first wedge 66 can be slidably attached tothe second wedge 68. The first wedge 66 can have a tongue 318. Thesecond wedge 68 can have a groove 320. The tongue 318 can be slidablyattached to the groove 320.

A gap 322 can be between the tongue 318 and the groove 320. The gap 322can be wider than the height of the teeth 316. The gap 322 can beconfigured to allow the first wedge 66 to be sufficiently distanced fromthe second wedge 68 so the teeth 316 on the first wedge 66 can bedisengaged from the teeth 316 on the second wedge 68.

The buttress 304 in a compact configuration can be placed inside of afully or partially deployed expandable support device 2. FIG. 135illustrates that the first wedge 66 can then be translated, as shown byarrows, relative to the second wedge 68 along the directionally lockinginterface 314. The first wedge 66 can abut a first side of the inside ofthe deployed expandable support device 2. The second wedge 68 can abut asecond side of the inside of the deployed expandable support device 2.The directionally interference fitting teeth 316 can preventdisengagement of the buttress 304. A stop 324 can limit the relativetranslation of the first wedge 66 and the second wedge 68.

FIGS. 136 through 139 illustrate another form of expandable supportdevice 2 of FIGS. 17 through 20 that can be in a deployed configuration.The first struts 84 can be expanded, as shown by arrows 326. Theexpandable support device 2 can be passively narrow, as shown by arrows330. The expandable support device 2 can be deployed in a configurationwhere the second struts 86 can be placed against the load bearingsurfaces of the deployment site.

The expandable support device 2 can have a minimum inner diameter 330and a maximum inner diameter 332. The minimum inner diameter 330 can beless than the pre-deployed inner diameter. The minimum inner diameter330 can be from about 0.2 mm (0.01 in.) to about 120 mm (4.7 in.), forexample about 2 mm (0.08 in.). The diameters 330 and/or 332 can also befrom about 1.5 mm (0.060 in.) to about 40 mm (2 in.), for example about8 mm (0.3 in.). The maximum inner diameter 332 can be more than thepre-deployed inner diameter. The maximum inner diameter 332 can be fromabout 1.5 mm (0.060 in.) to about 120 mm (4.7 in.), for example about 18mm (0.71 in.).

FIGS. 140 through 142 illustrate the expandable support device 2 ofFIGS. 31 through 34 that can be in a deployed configuration. A tool (notshown) can releasably attach to the tool engagement port 106. The toolcan be used to position the expandable support device 2. The tool can beused to expand the expandable support device 2, for example, by forcingthe first panels 96 toward each other.

The second joints 104 can form angles less than about 90°. As shown inFIG. 143, a compressive force, as shown by arrows 334, causes additionalinward deflection, as shown by arrows 336, of the first panels 96, andwill not substantially compress the expandable support device 2.

FIG. 144 illustrates a deployed configuration of the expandable supportdevice 2 of FIGS. 35 and 36. The first struts 84 can expand to the sizeof the expandable support device 2. FIG. 145 illustrates that the firststruts 84 can touch each other, for example if the expandable supportdevice 2 is sufficiently expanded. In the case of extreme compressiveloads applied to the expandable support device 2, the first struts 84can buckle into each other, thereby providing additional resistance tocompressive loads.

FIG. 146 illustrates the expandable support device 2 that can have oneor more bands 130. The bands 338 can be attached to other bands 338and/or attached to the expandable support device 2 with band connectors340. The bands 338 can be attached to the expandable support device 2before, during, or after deployment. The bands 338 can increase thecompressive strength of the expandable support device 2.

FIG. 147 illustrates a locking pin 196 configured and dimensioned to fitinto the longitudinal port 82, for example, of the expanded expandablesupport device 2 of FIGS. 136 through 139. FIG. 148 illustrates a thelocking pin 196 configured and dimensioned to fit into the longitudinalport 82, for example, of the expanded expandable support device 2 ofFIGS. 140 through 143. FIG. 149 illustrates a locking pin 196 configuredand dimensioned to fit into the longitudinal port 82, for example, ofthe expanded expandable support device 2 of FIGS. 24 and 25 and/or FIGS.27 and 28.

Once the expandable support device 2 is deployed, the longitudinal port82 and the remaining void volume in the damage site 146 can be filledwith, for example, biocompatible coils, bone cement, morselized bone,osteogenic powder, beads of bone, polymerizing fluid, paste, a matrix(e.g., containing an osteogenic agent and/or an anti-inflammatory agent,and/or any other agent disclosed supra), Orthofix, cyanoacrylate, orcombinations thereof.

The expandable support device 2 can be implanted in the place of all orpart of a vertebral disc 144. For example, if the disc 144 hasherniated, the expandable support device 2 can be implanted into thehernia in the disc 144 annulus, and/or the expandable support device 2can be implanted into the disc 144 nucleus.

PCT Application No. PCT/US2005/033965, Publication No. WO 2006/034396,entitled “Balloon and Methods of Making and Using”, filed Sep. 21, 2005,and U.S. Provisional Patent Application Ser. No. 60/611,972, filed onSep. 21, 2004, are herein incorporated by reference in their entireties.PCT Application No. PCT/US2005/034728, Publication No. WO 2006/068,682,entitled “Expandable Support Device and Method of Use”, filed Sep. 26,2005, and U.S. Provisional Patent Application No. 60/612,728, filed onSep. 24, 2004, are herein incorporated by reference in their entireties.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,without departing from the spirit and scope of the invention. Elementsshown with any variation are exemplary for the specific variation andcan be used on other variations within this disclosure. Any elementsdescribed herein as singular can be pluralized (i.e., anything describedas “one” can be more than one). Any species element of a genus elementcan have the characteristics or elements of any other species element ofthat genus. The above-described configurations, elements or completeassemblies and methods and their elements for carrying out theinvention, and variations of aspects of the invention can be combinedand modified with each other in any combination.

We claim:
 1. An expandable implant device comprising: a body having alength along a first axis, a width along a second axis, and a heightalong a third axis, and a substantially hollow interior; wherein thebody includes a first plurality of panels connected by flexible jointsbetween adjacent panels, and a second plurality of panels connected byflexible joints between adjacent panels, wherein the first and secondplurality of panels connect to end panels of the body, the body assuminga first, radially unexpanded configuration having a first length alongthe first axis, the body assuming a second, radially expandedconfiguration having a second length along the first axis, the secondlength being shorter than the first length, such that when the body isin the second, radially expanded configuration, the body is compressedalong the first axis and the first panels move away from each otheralong the second axis, and wherein when the body is in the first,radially unexpanded configuration a non-straight angle formed betweenadjacent panels of the first plurality of panels, and wherein at leastone of the first plurality of panels has a port extending through the atleast one panel; and wherein the body has openings at the ends of thebody along the first axis to engage a compression tool.
 2. The device ofclaim 1, wherein the first plurality of panels and the second pluralityof panels define first struts defining opposite walls of the device. 3.The device of claim 1, wherein the device has a first cross-section anda second cross-section substantially perpendicular to the firstcross-section, and wherein the first cross-section is rectangular, andwherein the second cross-section is rectangular.
 4. The device of claim1, further comprising a first end panel and a second end panel, whereinthe first end panel and the second end panel have openings therethrough.5. The device of claim 1, further comprising a substantially rigid firstend panel and a substantially rigid second end panel opposite to thefirst end panel.
 6. The device of claim 1, wherein the wall thickness ofthe device is from about 0.25 mm to about 5 mm.
 7. The device of claim1, wherein the first axis is perpendicular to the second axis.
 8. Thedevice of claim 1, wherein the second axis is perpendicular to the thirdaxis.
 9. The device of claim 1, wherein a first panel is attached to asecond panel at a flexible joint.
 10. The expandable implant of claim 1,wherein the first plurality of panels comprises three panels connectedby a pair of flexible joints.
 11. The expandable implant of claim 1,wherein the second plurality of panels comprises three panels connectedby a pair of flexible joints.
 12. The device of claim 1, furthercomprising struts connecting said first plurality of panels to saidsecond plurality of panels, wherein the struts are disposed within saidsubstantially hollow interior.
 13. The device of claim 1, wherein afirst panel in the first plurality of panels has a long edge and a shortedge, and wherein the first panel is connected to a second panel in thefirst plurality of panels along the long edge.
 14. The device of claim1, further comprising a first strut and a second strut, wherein thefirst strut is rotatably attached to the second strut, and wherein thefirst strut is attached to the first plurality of panels, and whereinthe second strut is attached to the second plurality of panels.
 15. Anexpandable implant device comprising: a body having a length, width andheight, and a substantially hollow interior; a first plurality ofinterconnected panels, wherein at least two adjacent panels of the firstplurality of interconnected panels form a non-straight angle with eachother when the device is in a longitudinally expanded radiallyconfiguration, and wherein at least one of the first plurality ofinterconnected panels has a port extending through the at least onepanel; a second plurality of interconnected panels positioned oppositeto the first panels; a first body end connecting said first plurality ofpanels to said second plurality of panels at a first end of the device,and a second body end connecting said first plurality of panels to saidsecond plurality of panels at a second end of the device; said firstbody end having a first tool engagement port and the second body endhaving a second tool engagement port, wherein a longitudinal axis isdefined between the first tool engagement port and the second toolengagement port, and wherein the first and second tool engagement portscan be configured to attach to a tool that can force the first toolengagement port toward the second tool engagement port; wherein atransverse axis is defined between the first plurality of panels and thesecond plurality of panels, and wherein the transverse axis isperpendicular to the longitudinal axis.
 16. The device of claim 15,wherein the body is configured to expand in height along the transverseaxis when the tool forces the first tool engagement port toward thesecond tool engagement port.
 17. The device of claim 15, wherein a firstpanel in the first plurality of interconnected panels has a long edgeand a short edge, and wherein the first panel is connected to a secondpanel in the first plurality of interconnected panels along the longedge.
 18. The device of claim 15, further comprising a first strut and asecond strut, wherein the first strut is rotatably attached to thesecond strut, and wherein the first strut is attached to the firstplurality of interconnected panels, and wherein the second strut isattached to the second plurality of interconnected panels.
 19. Anexpandable implant device comprising: a body having a length, width andheight, and a substantially hollow interior; wherein the body has afirst flat side comprising a first panel, and wherein the first panelhas a port extending through the first panel; wherein the body has asecond flat side comprising a second panel positioned opposite to thefirst panel; wherein the first panel is jointedly linked to the secondpanel; and wherein a non-straight angle is formed between the firstpanel and the second panel when the device is in a longitudinallyexpanded configuration.
 20. The device of claim 19, wherein the firstpanel has a long edge and a short edge, and wherein the first panel isjointedly linked to the second panel along the long edge.